Posology : מינונים

4.2   Posology and method of administration

Prior to initiating evolocumab, secondary causes of hyperlipidemia or mixed dyslipidemia (e.g., nephrotic syndrome, hypothyroidism) should be excluded.

Posology

Primary hypercholesterolemia and mixed dyslipidemia (including heterozygous familial hypercholesterolemia)

Adults and pediatric patients (aged 10 years and over)
The recommended dose of evolocumab is either 140 mg every two weeks or 420 mg once monthly; both doses are clinically equivalent.

Homozygous familial hypercholesterolemia in adults and pediatric patients aged 10 years and over The initial recommended dose is 420 mg once monthly. After 12 weeks of treatment, dose frequency can be up-titrated to 420 mg once every 2 weeks if a clinically meaningful response is not achieved. Patients on apheresis may initiate treatment with 420 mg every two weeks to correspond with their apheresis schedule.

Established atherosclerotic cardiovascular disease in adults
The recommended dose of evolocumab is either 140 mg every two weeks or 420 mg once monthly; both doses are clinically equivalent.

Special populations

Elderly patients (age ≥ 65 years)
No dose adjustment is necessary in elderly patients.
Patients with renal impairment
No dose adjustment is necessary in patients with renal impairment (see section 5.2).

Patients with hepatic impairment
No dose adjustment is necessary in patients with mild hepatic impairment, see section 4.4 for patients with moderate and severe hepatic impairment.

Pediatric population
The safety and effectiveness of Repatha have not been established in pediatric patients with heterozygous familial hypercholesterolemia (HeFH) or homozygous familial hypercholesterolemia (HoFH) who are younger than 10 years old or in pediatric patients with other types of hyperlipidemia.

Method of administration

Subcutaneous use.
Evolocumab is for subcutaneous injection into the abdomen, thigh or upper arm region. Injection sites should be rotated and injections should not be given into areas where the skin is tender, bruised, red, or hard.

Evolocumab must not be administered intravenously or intramuscularly.

Repatha 140 mg solution for injection in pre-filled syringe
The 140 mg dose should be delivered using a single pre-filled syringe. The 420 mg dose should be delivered using three pre-filled syringes administered consecutively within 30 minutes.

Repatha 140 mg solution for injection in pre-filled pen
The 140 mg dose should be delivered using a single pre-filled pen. The 420 mg dose should be delivered using three pre-filled pens administered consecutively within 30 minutes.

Repatha is intended for patient self-administration after proper training. Administration of evolocumab can also be performed by an individual who has been trained to administer the product.

For single use only.